The Recall Desk

FDA (Devices) recall action 95124

Boston Scientific Corporation recalled 31 products on 2024-10-02

The FDA (Devices) publishes a recall like this one as 31 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 31 pages.

Products
31
Announced
2024-10-02
Critical
0
Units
4,141

Why these products were recalled

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–31 of 31

  • HighFDA (Devices)··2024-10-02

    FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk

    Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-02

    WallFlex Esophageal Stent System Recalled Due to Catheter Tip Detachment Risk

    Boston Scientific recalls WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment affecting 77 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esop
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-02

    Boston Scientific Agile Esophageal Stent Recall: Catheter Tip Detachment Risk

    Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.

    Product
    AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of conc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-02

    Esophageal stent systems recalled due to delivery catheter tip detachment risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.

    Product
    WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-02

    Boston Scientific Esophageal Stent Systems Recalled for Catheter Tip Detachment Risk

    Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.

    Product
    AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.

    Product
    AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Distribution
    0 states